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Maxframe 03.312.004

by Synthes

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10886982362353 UDI-DI Date30 Jun 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Maxframe
Generic Name
External orthopaedic fixation system data communication/home-use monitoring software
Model / Ref / Catalog
03.312.004, 03312004
Primary DI / UDI-DI
10886982362353
510(k) Number
FDA Product Code
OSN, KTT
GMDN Term
External orthopaedic fixation system data communication/home-use monitoring software
Device Class
Class II
Regulation Number
888.3030
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K254087)

Other devices from Synthes

See all devices from Synthes →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No